The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

NCT ID: NCT01691781

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-12-31

Brief Summary

This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Detailed Description

The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.

Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:

1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?

2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?

The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.

Conditions

Hyperparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

lisinopril

Lisinopril - open-label, 2.5-40mg daily

Group Type: EXPERIMENTAL

Lisinopril

Intervention Type: DRUG

Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Interventions

Lisinopril

Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
• normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
• Age >18 years and <80 years
• Estimated GFR > 60ml/min

Exclusion Criteria

• Chronic Kidney Disease or eGFR<60
• Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
• Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
• History of liver failure
• History of heart failure
• The use of typical or atypical antipsychotic medications or lithium.
• Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
• The use of prescribed doses of potassium supplements.
• Illness requiring overnight hospitalization in the past 6 months
• Active tobacco or recreational drug use
• Pregnancy or current breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anand Vaidya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand Vaidya, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Harvard Medical School

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Zaheer S, Brown JM, Connors M, Williams JS, Adler GK, Vaidya A. Angiotensin-Converting Enzyme Inhibition and Parathyroid Hormone Secretion. Int J Endocrinol. 2017;2017:4138783. doi: 10.1155/2017/4138783. Epub 2017 Jul 20.

Reference Type: DERIVED

PMID: 28808443 (View on PubMed)

Other Identifiers

2012p0001961

Identifier Type: -

Identifier Source: org_study_id